Why it was recalled
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
Product description
FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01
Lot numbers, UPCs & expiration codes
Lot# 31327913C, Exp. Date 10/2022
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0765-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 30, 2021
- FDA report date
- Sep 1, 2021
- Quantity
- 19,384 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Custopharm, Inc.
Original FDA data
Every field from FDA enforcement report D-0765-2021, exactly as published.
Show all FDA fields
- City
- Carlsbad
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 88489
- Address
- 2325 Camino Vida Roble
- Code information
- Lot# 31327913C, Exp. Date 10/2022
- Postal code
- 92011-1567
- Report date
- Sep 1, 2021
- Product type
- Drugs
- Recall number
- D-0765-2021
- Classification
- Class II
- Recalling firm
- Custopharm, Inc.
- Product quantity
- 19,384 vials
- Termination date
- Aug 8, 2022
- Reason for recall
- Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jul 30, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 23, 2021